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Petition on Vitamin D Yeast Approved

October 17, 2012

PETITION ON VITAMIN D YEAST APPROVED…

A December 2009 petition asking the Food and Drug Administration to allow the use of vitamin D2 bakers yeast in baked foods at higher levels was approved Aug. 29 by the agency, effective immediately. The final rule was published in the Aug. 29 edition of the Federal Register. Under the ruling, bakers may use the yeast at levels not to exceed 400 international units (I.U.) of vitamin D per 100 grams in the finished foods, up from 90 I.U. previously. The F.D.A. acted in response to a petition filed by Lallemand, Inc., which markets yeast with vitamin D. In its 2009 petition, Lallemand sought approval of vitamin D2 yeast as a dual purpose nutrient supplement and leavening agent or dough relaxer in yeast-containing baked foods. Specifically, the foods named in the petition are yeast-leavened baked foods, baking mixes and yeast-leavened baked snack foods. Later, the petition was amended to exclude the use of the additive as a dough relaxer. Additionally, vitamin D has been affirmed as GRAS in other products, including infant formula, margarine, calcium-fortifiedfruit juices, meal replacement and other types of bars and cheese substitutes.

F.D.A. STUDIED RISK OF EXCESSIVE INTAKE…

While essential to human health, excessive intake of vitamin D may be harmful, elevating blood plasma calcium levels, the F.D.A. said. Much of the F.D.A.’s work on the petition was around analysis conducted by Lallemand as to whether approval of the condition could lead to excessive intake. The company generated data estimating mean and 90th percentile estimates of vitamin D intake for consumers of current products in addition to proposed uses. Lallemand estimated, and the F.D.A. approved, the methodology for the estimate, that intake of vitamin D from all food sources for the U.S. population at the 90th percentile would be 1,670 I.U. per day, including consumers of yeast-leavened baked products covered by the petition.

While a 1997group at the Institute of Medicine established an upper limit of 2,000 I.U. per day for anyone older than 1 year of age, the F.D.A. noted the limits were raised last year. In the revisions, the I.O.M. established upper limits for vitamin D intake to 2,500 I.U. for children 1 year to 3 years of age, 3,000 for children aged 4 to 8, and 4,000 for children aged 9 to 18 and adults. In its review of the safety of the dietary intake of vitamin D2 that would result from approval of the petition, the F.D.A. concluded that the 1,670 I.U., anticipated as the 90th percentile intake level, is below the lowest upper limit set by the I.O.M. for individuals 1 year old and older.